ISO 14000

Environmental Health & Safety Management Guide (EHS)

We have achieved improved dependability as well as standardization in our processes to assure measurement consistency and the required monitoring to verify conformity in our products. This adds enhanced safety and quality to our customers.
Helton Calaça – SPC Technical Support

SE Document manages ISO standardization documentation to facilitate compliance, as well as all other document types. The workflow system provides great distribution copy control, approval, revision, printed copies, and document retrieval search capabilities. Currently, there are over 1,100 users and 3,500 registered documents.
Carla Regina Schmitt

The SE Project was implemented quickly and the time required for the adoption of the solution by the users was quite natural, considering that the pharmaceutical segment is legally required to work with reliable and secure records that guarantee the quality of products and do not represent risks to the population.
Randel Moreira – IT Manager

Our productivity and reliability increased greatly. The software helped us to meet the ISO/TS 16949 standard requirements, providing security in the daily routine of the Engineering area and auditing, while easily proving full compliance with the standard and customer requirements.
Jeferson R. F. dos Santos – MENFUND Unit Manager

SE Document has provided the means to streamline our document control, through excellent drilldown options for searching and registering documents, a systematic workflow
tool for sending pending tasks to system users, as well as really cutting down on the need for printed copies.
Ângela Fischer

SoftExpert Solution has streamlined data sharing for our quality system and has contributed to reducing impacts on the environment through doing away with the need for storing piles of original and obsolete paper documents for auditing purposes.
Solange Amaral – Human Resource Analyst

Online access to wherever we offer services ensures us speedy responses, through reliable and updated information, which, in turn, facilitates decision making and customer satisfaction.
José Andrade – Opetrec Manager

SE Document completely meets our document control requirements, facilitates retrieval, and manages the entire document revision process.
Janaina Salatti – Quality Supervisor

The implementation of SE Action streamlined our continuous improvement process for managing actions, especially through the workflow functionality. This facilitates the verification of occurrence causes and drafting correction actions.
Gustavo Martins – Quality Department Assistant

The SoftExpert facilitates and speeds up activities, and the system was considered highly suitable for the renewal of ISO/TS 16949 and ISO 14001.
Cristina Pereira – Gerente adjunta de Inform�tica

Overview
The Solution

In accordance with the International Organization for Standardization – ISO, the ISO 14000 family addresses the company’s Environmental Management System – EMS. An organization with an effective EMS, will be able to::
- minimize harmful effects to the environment caused by its activities, and
- achieve continual improvement of its environmental performance.
In accordance with the International Organization for Standardization – ISO, the ISO 14000 family addresses the company's Environmental Management System – EMS. An organization with an effective EMS, will be able to::
- minimize harmful effects to the environment caused by its activities, and
- achieve continual improvement of its environmental performance.
An EMS that meets the requirements of the ISO 14000 family becomes a management tool that allows organizations of any size or type to:
- identify and control the environmental impact of its activities, products or services
- improve its environmental performance continually
- implement a systematic approach to establishing environmental objectives and targets, to achieving them and to demonstrating that they have been achieved.
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The Challenge

ISO 14000 family is a tool that can be used to meet internal objectives:
- ensure top management the assurance full control over organizational processes and activities that may impact the environment
- ensure employees that they are working for an environmentally-responsible organization.
ISO 14000 family is a tool that can be used to meet internal objectives:
- ensure top management the assurance full control over organizational processes and activities that may impact the environment
- ensure employees that they are working for an environmentally-responsible organization.
ISO 14000 family can also be used to meet external objectives:
- guarantee compliance with environmental issues for external stakeholders – such as customers, the community and regulatory agencies,
- comply with environmental regulations,
- support the organization's claims and communication about its own environmental policies, plans and actions,
- provide a framework for demonstrating conformity via suppliers' declarations of conformity, assessment of conformity by an external stakeholder - such as a business client - and certification of conformity by an independent certification body.
In order to help organizations meet these challenges, SoftExpert offers a complete, fully Web-based solution that simplifies the control of processes, products and services, environmental aspects and impacts, legal and other requirements, documents, records and audits. SoftExpert is a comprehensive solution that covers all the requirements determined by the ISO 14000 family and related regulations.

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Each SoftExpert component addresses key compliance issues as shown below:

Module	Compliance and Requirements
SE Action Plan **	Helps organizations effectively coordinate and manage the entire workflow by maintaining team communication and improving collaboration through the centralized control of action plan and task planning, execution and monitoring, including o corrective, preventive or predictive actions.
SE Audit	Manages the entire process by: Planning and executing first, second and third part audits. Programming audits, taking into consideration the scope, status and importance of the processes and/or areas to be audited. Defining criteria, methods, responsibilities and requirements to be audited. Selecting auditors according to their skills, ensuring that they will not audit their own work. Records respository: Audits and their results. Evidence ocurrences¹. Disposition action and CAPA¹. Cause analysis¹. Follow-up activities¹. Verification of the actions taken¹.
SE BI	Helps identify, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the environmental management system.
SE Calibration **	Helps ensure that monitoring and measurement equipment is properly calibrated and/or verified, and that associated calibration records are maintained.
SE Competence *	Helps the organization to: Ensure that any person performing tasks for it or on its behalf that have the potential to cause a significant EHS risk identified by the organization is competent based on appropriate education and/or experience. Establish, implement and maintain procedures to ensure that the people working for it or on its behalf are aware of: The importance of conformity with the EHSM policy and procedures and the requirements of the management system. The significant EHS risks and related actual or potential impacts associated with their work, as well as the benefits of improved personal performance. Their roles and responsibilities achieving conformity with the management system requirements. The potential consequences of deviation from the specified procedures.
SE Document	Manages the entire process by: Elaborating, reviewing and approving documents for adequacy prior to issue. Reviewing and updating as necessary and re-approving documents. Identifying, storing, protecting, retrieving, retaining and disposing of records. Ensures that: Changes and the current revision status of documents are identified. Relevant versions of applicable documents are available. Documents and records remain legible and readily identifiable. Documents of external origin determined by the organization are identified and their distribution controlled. Prevents the unintended use of obsolete documents, and suitably identifies them if they are retained for any purpose.
SE Maintenance **	Ensures the availability of the infrastructure essential for establishing, implementing, maintaining and improving the environmental management system.
SE Performance	Manages the entire process by: Establishing, implementing, maintaining and analyzing objectives, indicators and targets for following the policy established by the organization, including its commitment to: It’s significant EHS risks. The prevention of pollution. Compliance with applicable legal requirements and other requirements that apply to the organization. Continuous improvement. Its technological options, its financial, operational and business requirements and the views of interested parties. Deploying objectives, indicators and targets at relevant functions and levels within the organization. Designating the responsibility for achieving the objectives and targets at relevant functions and levels of the organization. Defining adequate means and time-frames for monitoring and, where applicable, measuring the objectives, indicators, targets and processes established by the organization.
SE Process	Manages the entire process by: Defining the processes needed and their application throughout the organization. Determining the sequence, interaction and EHS risks of these processes. Determining the criteria and methods required to ensure that both the operation and control of these processes are effective and mitigate EHS risks. Defining the resources and information necessary to support the operation and monitoring of these processes. Defining the monitoring and measurement points, where applicable, and analyzing these processes. Implementing the actions necessary to achieve planned results and continually improve these processes.
SE Project *	Manages the entire process by: Establishing, implementing, maintaining and analyzing the action plans (programs) for following the policy established by the organization. Deploying action plans at relevant functions and levels within the organization. Designating the responsibility for completing action plans at relevant functions and levels of the organization. Defining adequate means and time-frames for the monitoring and, where applicable, measurement of action plans established by the organization.
SE Request	Manages the entire identification process through: Requirements specified by the interested parties (customer, shareholders, employees, suppliers and community). Requirements not stated by the customer but necessary for specified or intended use, where known. Statutory and regulatory requirements applicable to the product and the process. Any additional requirements considered necessary by the organization with aims of enhancing customer satisfaction.
SE Risk	Helps the organization to: Manage the risks associated with its organizational environment and related changes. Ensure that the significant EHS risks are taken into account when establishing, implementing and maintaining its management system. Manages the entire process by: Identifying the EHS risks of its activities, products and services within the defined scope of the management system that it can control and those it can influence. Determining those EHS risks that have or can have significant impacts. Documenting this information and keeping it up to date.
SE Training *	Helps the organization: Ensure that any person performing tasks for it or on its behalf that have the potential to cause a significant EHS risk identified by the organization is competent based on appropriate training. Identify training needs associated with its EHS Risks and its management system. Provide training or take other actions to meet these needs. Retain associated records.
SE Waste *	Manages the entire process of identification and planning of operations related to waste, including: The storage, transportation and disposal of generated waste. The management of the complete lifecycle of waste by-products, starting with the generation, on to processing and finally to the final disposal. Provides consistency and accuracy through standardized waste profiles. Ensures streamlined waste management information organization-wide. Effortlessly tracks waste inventories, including accumulation, storage, containers and lab packs.
SE Workflow **	Automates and controls workflows within the production environment, assigning process tasks to the right team, role or individual at the appropriate time, based on the processes that were mapped in SE Process.